Sonicaid Freedom Wireless Fetal Monitoring System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K132650 FDA 510(k)
- FDA Product Code
- HGM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.2740 FDA 510(k)
- Regulation Number
- 884.2740 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Sonicaid Freedom Wireless Fetal Monitoring System is a wireless device designed for monitoring fetal heart rate and maternal contractions. Classified as a perinatal monitoring system, it provides real-time data to assess fetal well-being during both antepartum and intrapartum periods of pregnancy.
This system consists of wireless transducers for fetal heart rate and contractions, paired with a receiver base unit. Supplied as a non-sterile, reusable device, it is intended for use in clinical obstetric settings. The system operates within Class II regulatory classification and holds an FDA 510(k) clearance under the designation K132650, with registration numbers including 1930027 and others listed. Storage and handling follow standard medical device protocols for reusable equipment.
Frequently asked questions
What clinical scenarios is the Sonicaid Freedom Wireless Fetal Monitoring System intended for use in during pregnancy?
The Sonicaid Freedom Wireless Fetal Monitoring System is designed for monitoring fetal heart rate and maternal contractions during both antepartum (prior to labor) and intrapartum (during labor) periods. This allows clinicians to continuously assess fetal well-being in clinical obstetric settings, ensuring timely intervention if needed.
Is the Sonicaid Freedom Wireless Fetal Monitoring System reusable or single-use, and what does this mean for its maintenance?
The Sonicaid Freedom Wireless Fetal Monitoring System is supplied as a non-sterile, reusable device. This means it is intended for repeated use across multiple patients, but it must be thoroughly cleaned, disinfected, and maintained according to standard medical device protocols for reusable equipment to ensure safety and functionality between uses.
How is the device supplied, and what components are included in the system?
The system consists of wireless transducers for fetal heart rate and contractions, paired with a receiver base unit. These components work together to transmit real-time data wirelessly, eliminating the need for physical cable connections. The system is designed for clinical obstetric use and is not supplied sterile.
What regulatory pathway was followed for FDA clearance of the Sonicaid Freedom Wireless Fetal Monitoring System?
The Sonicaid Freedom Wireless Fetal Monitoring System received FDA 510(k) clearance under the designation K132650, classified as a Class II device. The submission was reviewed by the Obstetrics/Gynecology (OB) Advisory Committee and determined to be substantially equivalent to a predicate device. The clearance was granted on February 7, 2014, following a traditional review process.
Does the device require special storage conditions, and if so, what are the key considerations?
The Sonicaid Freedom Wireless Fetal Monitoring System follows standard medical device protocols for reusable equipment during storage and handling. While specific storage conditions (e.g., temperature, humidity) are not detailed in the data, it is critical to adhere to manufacturer guidelines to prevent damage, ensure calibration accuracy, and maintain functionality for repeated clinical use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Freedom - huntleigh-diagnostics.com, Fetal Monitors - Huntleigh Healthcare, Huntleigh Healthcare Huntleigh Diagnostic Division SF1TOCO Wireless ..., Sonicaid Freedom Wireless Fetal Monitoring System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132650 | Class II | Active |
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Manufacturer
- Manufacturer
- Huntleigh Healthcare Limited
Sources (1)
- FDA 510(k) K132650 24 fields · synced Oct 6, 2026